The present invention relates to an implantable prosthesis, and more particularly to a prosthetic repair fabric for use in soft tissue repair and reconstruction.
Gastroesophageal reflux disease (xe2x80x9cGERDxe2x80x9d) and hiatal hernia commonly occur together. A hiatal hernia occurs when a natural opening, or xe2x80x9chiatus,xe2x80x9d in the diaphragm through which the esophagus extends, becomes enlarged, allowing the stomach to pass through the hiatus into the thoracic cavity. GERD indicates a backflow of acid from the stomach into the esophagus. Although GERD may be an independent affliction, GERD is often a symptom of, or a co-affliction with, a hiatal hernia. Representative surgical treatments for GERD and/or hiatal hernia may include one or more of the following: a fundoplication, more specifically an open or laparoscopic Nissen fundoplication, where part of the fundus of the stomach is wrapped around the lower end of the esophagus to recreate or augment the lower esophageal sphincter (LES); a cruroplasty, which involves tightening the crura of the diaphragm around the esophagus; and an endoscopic gastroplication where pleats are formed within the esophagus at or near the LES, reducing the size of the internal diameter of the lower esophagus.
It has been known to use a prosthetic repair fabric in the surgical treatment of GERD and/or hiatal hernia. Typically, a sheet of surgical mesh fabric, such as BARD MESH, commercially available in rectangular stock sheets, is custom fashioned by a surgeon into a shape suitable for a particular patient""s hiatal repair, such as a rectangular or oval shape. The surgeon forms a keyhole opening in the patch by cutting a slit from one edge of the implant and then forming an opening at the end of the slit that is large enough to receive the esophagus. The adjacent flaps of mesh formed by the slit running through the edge, known as xe2x80x9ctailsxe2x80x9d or xe2x80x9cfinsxe2x80x9d, may be stitched together after the esophagus has been positioned in the keyhole opening, recreating a hiatal ring about the esophagus to help prevent the stomach from reentering the thoracic cavity.
It is one object of certain embodiments of the present invention to provide a preformed prosthesis for the treatment of GERD and/or the repair of hiatal hernias.
It is another object of certain embodiments of the present invention to provide a prosthesis for the treatment of GERD and/or the repair of hiatal hernias that reduces the incidence of postoperative adhesions to the esophagus, stomach and/or other surrounding viscera.
It is a further object of certain embodiments of the present invention to provide methods of treating GERD and/or repairing hiatal hernias.
In one embodiment of the invention, an implantable prosthesis is provided for repairing a tissue or muscle wall defect located near the esophagus. The implantable prosthesis comprises a layer of repair fabric that is susceptible to the formation of adhesions with tissue and organs, a surface barrier that inhibits the formation of adhesions with tissue and organs, and at least one edge barrier that inhibits the formation of adhesions with tissue and organs. The layer of repair fabric includes first and second surfaces and at least one fabric edge extending from the first surface to the second surface. The first surface is adapted to face the tissue or muscle wall defect when the implantable prosthesis is placed in a patient near the esophagus, and the second surface is adapted to face away from the tissue or muscle wall defect and toward the patient""s cavity viscera. The layer of repair fabric has an opening that is adapted to receive the esophagus. The surface barrier is disposed on at least a portion of the second surface of the layer of repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the implantable prosthesis is placed in the patient. The at least one edge barrier extends about at least a portion of the at least one fabric edge to inhibit the formation of adhesions between the portion of the at least one fabric edge and adjacent tissue and organs.
In another embodiment of the invention, an implantable prosthesis is provided for repairing a tissue or muscle wall defect located near a tube-like structure. The implantable prosthesis comprises a body portion that is constructed and arranged to be placed proximate the tissue or muscle wall defect, and includes an outer periphery and has an opening that is adapted to receive the tube-like structure. The body portion comprises a layer of repair fabric that is susceptible to the formation of adhesions with tissue and organs, and a surface barrier that inhibits the formation of adhesions. The layer of repair fabric includes first and second surfaces and at least one fabric edge extending from the first surface to the second surface. The first surface is adapted to face the tissue or muscle wall defect when the implantable prosthesis is placed in a patient near the tube-like structure. The layer of repair fabric has a first slit extending from the opening to the outer periphery to receive the tube-like structure in the opening. The surface barrier is disposed at the second surface of the layer of repair fabric to inhibit the formation of adhesions on the second surface when the implantable prosthesis is placed in the patient. The surface barrier has a second slit extending from the opening to the outer periphery to receive the tube-like structure in the opening. The second slit is offset from the first slit, such that the second slit overlies a portion of the layer of repair fabric and the first slit overlies a portion of the surface barrier.
In yet another embodiment of the invention, an implantable prosthesis is provided for repairing a tissue or muscle wall defect located near a tube-like structure. The implantable prosthesis comprises a body portion that is constructed and arranged to be placed proximate the tissue or muscle wall defect, and includes an outer periphery and has an opening that is adapted to receive the tube-like structure. The body portion comprises a layer of repair fabric that is susceptible to the formation of adhesions with tissue and organs, and a plurality of barriers that inhibit the formation of adhesions on selected portions of the layer of repair fabric when the implantable prosthesis is placed in the patient. The layer of repair fabric includes first and second surfaces, an outer peripheral edge and an opening edge. The first surface is adapted to face the tissue or muscle wall defect when the implantable prosthesis is placed in a patient near the tube-like structure. The outer peripheral edge extends from the first surface to the second surface along the outer periphery, and the opening edge extends from the first surface to the second surface along the opening. The plurality of barriers includes a surface barrier that is disposed on at least a portion of the second surface of the layer of repair fabric, a peripheral edge barrier that is disposed along at least a portion of the outer peripheral edge of the layer of repair fabric, and an opening edge barrier that is disposed along at least a portion of the opening edge of the layer of repair fabric.
In a further embodiment of the invention, an implantable prosthesis is provided for repairing a tissue or muscle wall defect located near a tube-like structure. The implantable prosthesis comprises a prosthetic repair fabric that includes an outer periphery and has an opening therein that is adapted to receive the tube-like structure. The prosthetic repair fabric includes first and second segments, each of the first and second segments including a layer of fabric that is susceptible to the formation of adhesions with tissue and organs. Each of the first and second segments includes a first end and a second end, the first end of the first segment overlapping the first end of the second segment at a first overlap area, the second end of the first segment overlapping the second end of the second segment at a second overlap area. The first segment includes a first mid-portion between the first and second overlap areas and the second segment includes a second mid-portion between the first and second overlap areas. Each of the first and second mid-portions forms a portion of the outer periphery of the prosthetic repair fabric that is equal to or greater than approximately 90 degrees.
In another embodiment of the invention, an implantable prosthesis is provided for repairing a tissue or muscle wall defect located near a tube-like structure. The implantable prosthesis comprises a prosthetic repair fabric having an opening that is adapted to receive the tube-like structure, and includes first and second segments. Each of the first and second segments includes a layer of repair fabric that is susceptible to the formation of adhesions with tissue and organs and a surface barrier that inhibits the formation of adhesions with tissue and organs. The surface barrier is disposed on a surface of the layer of repair fabric. Each of the first and second segments includes a first end and a second end, the first end of the first segment overlapping the first end of the second segment at a first overlap area. The first overlap area is free of one of the layer of fabric and the surface barrier of at least one of the first and second segments.
In a further embodiment of the invention, a prosthetic repair fabric comprises a body portion of implantable, biocompatible prosthetic material. The body portion includes a middle section having a first width and a pair of end portions extending in a longitudinal direction from opposite sides of the middle section. Each end portion has a second width that is greater than the first width.
In yet another embodiment of the invention, a method is provided for treating gastroesophageal reflux disease. The method comprises creating at least one external fold on the external wall of the esophagus; and cinching the at least one external fold to create at least one external plication on the esophagus.
Other objects and features of the present invention will become apparent from the following detailed description when taken in connection with the accompanying drawings. It is to be understood that the drawings are designed for the purpose of illustration only and are not intended as a definition of the limits of the invention.